The OxyPLEASURE Study - Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency (Central Diabetes Insipidus) and Healthy Controls - a Double-blind Randomized Placebo-controlled Crossover Trial

NCT06808516 Phase 2 RECRUITING

The study aims to investigate whether intranasal oxytocin (OXT) improves sexual well-being in patients with Arginine Vasopressin Deficiency (AVP-D). The trial consists of two parts: Part A assesses the effect of OXT on sexual well-being and intimacy over a 7-day treatment period in participants in a stable partnership. Part B assesses the effect of a single dose OXT on sexual arousal, fear and empathy in a clinical setting and is designed for single participants and those in partnerships.

Details

Lead sponsor	University Hospital, Basel, Switzerland
Phase	Phase 2
Status	RECRUITING
Enrolment	42
Start date	2025-07-01
Completion	2026-12

Conditions

• Arginine Vasopressin Deficiency
• Central Diabetes Insipidus
• Oxytocin Deficiency

Interventions

• Oxytocin nasal spray
• Placebo

Primary outcomes

• Arizona Sexual Experience Scale (ASEX) (Part A) — before treatment and after the 7 day treatement period
  Subjective improvement in sexual well-being and intimacy, defined as a score decrease of 3 or more points on the ASEX (score range: 5-30). Only assessed in Part A
• New Sexual Satisfaction Scale (NSSS-S) (Part A) — before treatment and after the 7 day treatement period
  Subjective improvement in sexual well-being and intimacy, with an increase of 3 or more points on the NSSS-S (score range: 12-60). Only assessed in Part A

Countries

Switzerland